Summary
Overview
Work History
Education
Skills
Accomplishments
Employment Position
Personal Information
Timeline
Generic

Kani Mozhi Ganesan

Coimbatore

Summary

To work in an organization that provides the opportunity to utilize my professional expertise effectively and creatively to meet the organizational goals and an environment conducive to the realization of my personal potential.

Overview

5
5
years of professional experience

Work History

Quality Control - In Charge Instruments

Biosystems Diagnostics
Kanchipuram
01.2019 - 01.2022
  • SOP Preparation and Review pertaining to QC testing.
  • Follow the ISO 13485 to maintain the QC testing documentation as per it's requirement.
  • Review of obtained Final Control test results and its Instrument Release Certificate.
  • Review of testing results of components performed in incoming inspection.
  • Review of Calibration related activities and record review as per the requirement.
  • Review of Device History Record after completion of assembly and final control.
  • Instrument - BTS complaint review, compilation and follow up on Product Complaint Record.
  • Process validation documentation related to QC.
  • Review of the Internal Study reports and record the issues in the document as per the requirement.
  • Supporting team member in Risk analysis and prepare risk management report related to Manufacturing of instruments.
  • Preparation of Technical Documentation as per IVDR 2017/746.

QA Executive

Biosystems Diagnostics
Kanchipuram
01.2018 - 01.2019
  • Archival, documentation of Master, distribution of Controlled copies of Effective SOP's as per the user department requirement.
  • Supporting team member in Investigation of non-conformance batches and its documentation.
  • Preparation of Stability Schedule, Reports and Submission to Department Head.
  • Supporting team member in preparing schedule and receipt of instruments due for Calibration to External Calibration Agency.
  • Team member as an auditee in ISO, cGMP and other client Audits and in helping closure of audit observations.
  • Attending several internal and External Training programmes related to ISO 13485.
  • Conduct Revised SOP Training and QMS training as per the requirement.
  • Manage all quality related activities
  • Review process control plan, drive quality issues to root cause, corrective actions and improvement, track quality performance.
  • Coordinate customer visits and audits
  • Assist in developing quality goals and improvement plans.
  • Documentation and procedure compliance related to QMS System
  • Establish, Preparation of quality procedures an conduct training for the User department.
  • Possess skills in Process yield monitoring, Quality Improvement, Failure Analysis, FMEA.
  • Involve in all QA related activities and closure of all QMS related documents.

QC/QA Trainee

Biosystems Diagnostics
Kanchipuram
01.2017 - 01.2018
  • Analysis of In process-Bulk, Semi-finished product Filling and Finished product Samples.
  • Sampling of Raw-material, Packing Materials, analysis, release and documentation of the same.
  • Sampling of Purified Water samples, Effluent Water samples on schedule basis to external Laboratory.
  • Calibration and Control procedures of Laboratory Instruments - pH meter, Conductivity meter, Photometer and Auto analyser etc.
  • Status labelling and identification of Finished, Stability and Retained samples and maintenance of associated documents.
  • Preparation of QC/QA related SOP's, Formats and other GMP records as per cGMP, ISO 13485 guidelines.
  • Active participation in analysis of NC batches, under study batches etc.
  • Analysis and documentation of External Laboratory Assessment Programmes of Bio systems BS.

Education

Msc. Applied Microbiology -

Madras Christian College affiliated to Madras University
01.2016

Bsc. Microbiology -

PSG College of Arts and Science affiliated to Bharathiar University
01.2014

Alvernia Matric; Hig; Sec; School -

01.2011

Skills

  • Handling of Internal Audit as per ISO 13485, Trained at BSI
  • Handled Internal QMS Training as per ISO 13485
  • External Auditee - ENsure the compliance as per ISO 13485
  • Ability to Diagnose, analyze the issues in the Production and QC In-Line at Instruments and Troubleshooting guide prepared for preventing or resolving the issues
  • Attended Risk Management Training as per ISO 14971
  • Supporting Team member in Risk analysis and GAP Analysis
  • Awarded as Best Employee of 2019,2020 & 2021
  • Dubai trip 2020 - Conference held in Dubai , as project compliment
  • Technical document preparation as per MDR 2017 For Semi auto analyzer/ Device Master file preparation / Validation
  • Practical experience in Handling of Semi Auto & Auto analyzers, HA Analyzer / Internal Batch study for NC , Stability Study test & Report generation as per the requirement
  • QMS Documentation Control - Document Preparation & Review related to QC and QA
  • Customer Compliant Handling as per the Requirement
  • Multitasking

Accomplishments

Dubai Trip - Conference 2020 - As a compliment - working under Instrument manufacturing Project.

Employment Position

QA/QC

Personal Information

  • Date of Birth: 03/20/1993
  • Nationality: Indian

Timeline

Quality Control - In Charge Instruments

Biosystems Diagnostics
01.2019 - 01.2022

QA Executive

Biosystems Diagnostics
01.2018 - 01.2019

QC/QA Trainee

Biosystems Diagnostics
01.2017 - 01.2018

Msc. Applied Microbiology -

Madras Christian College affiliated to Madras University

Bsc. Microbiology -

PSG College of Arts and Science affiliated to Bharathiar University

Alvernia Matric; Hig; Sec; School -

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Kani Mozhi Ganesan